Document Number: DQ-OSD-TMD-001
Version: 1.0
Effective Date: YYYY-MM-DD
Prepared By: [Name]
Approved By: [Name]
Design Qualification Protocol for Inline Tablet Metal Detector
Objective: To establish a Design Qualification (DQ) protocol for the Inline Tablet Metal Detector to ensure it meets the required specifications for detecting metal contamination in solid dosage forms.
Scope: This protocol applies to the installation and qualification of the Inline Tablet Metal Detector within the Production/Compression area, impacting product quality directly.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for providing operational support during the qualification process.
Prerequisites:
- Completion of User Requirements Specification (URS).
- Installation of the Inline Tablet Metal Detector.
- Training of personnel on the operation of the equipment.
Equipment Description:
The Inline Tablet Metal Detector is designed to detect metal contaminants in solid dosage forms during the production process. It operates continuously as tablets pass through the detection area, ensuring immediate identification of any metal contamination.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TMD-DQ-01 | Verify installation and setup of the Inline Tablet Metal Detector. | All components installed per manufacturer’s specifications. | Installation checklist signed off. |
| TMD-DQ-02 | Perform sensitivity reject verification. | Detector rejects specified metal samples at defined sensitivity levels. | Test results and rejection logs. |
| TMD-DQ-03 | Audit trail verification. | Audit trail logs are complete and compliant. | Audit trail report. |
Detailed Test Cases:
- Test Case TMD-DQ-01: Confirm installation of the Inline Tablet Metal Detector by reviewing installation documentation and physical inspection.
- Test Case TMD-DQ-02: Conduct sensitivity testing using metal samples of varying sizes and materials. Document the detector’s response to each sample.
- Test Case TMD-DQ-03: Review and validate the audit trail functionality by generating reports and confirming data integrity.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented as necessary.
Approvals:
Prepared By: ____________________ Date: ____________
Approved By: ____________________ Date: ____________
Data Integrity Checks:
- Ensure all data generated during testing is logged automatically by the system.
- Regular backups of audit trail logs should be performed.
- Access controls must be in place to restrict unauthorized modifications.